ID

39010

Beschrijving

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01652729

Link

https://clinicaltrials.gov/show/NCT01652729

Trefwoorden

Versies (1)
  1. 19-11-19 19-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Type 2 NCT01652729

Engels

Eligibility Diabetes Type 2 NCT01652729

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes mellitus
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
hba1c of 7.1% to 11.0%, inclusive, at screening
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
Beschrijving

Stable body weight

Datatype

boolean

Alias
UMLS CUI [1]
C0517386
fasting plasma glucose concentration <280 mg/dl (15.5 mmol/l) at screening
Beschrijving

Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
body mass index of <45 kg/m2 at screening
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to visit 1 (screening)
Beschrijving

Metformin Dose Stable U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of pancreatitis or triglycerides >=500 mg/dl
Beschrijving

Pancreatitis | Triglycerides measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0202236
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
Beschrijving

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Datatype

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
history of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 ml/min
Beschrijving

Kidney Transplantation | Dialysis procedure | Estimated creatine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C1273051
active cardiovascular disease
Beschrijving

Cardiovascular Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
presence or history of severe congestive heart failure
Beschrijving

Congestive heart failure Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205082
central nervous system disease, including epilepsy
Beschrijving

CNS disorder | Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0014544
liver disease
Beschrijving

Liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
history of severe gastrointestinal diseases
Beschrijving

Gastrointestinal Diseases Severe (

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205082
clinically significant malignant disease
Beschrijving

Malignant disease

Datatype

boolean

Alias
UMLS CUI [1]
C0442867
repeated severe hypoglycemia within the last 6 months
Beschrijving

Hypoglycemia Severe Repeated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205341
any exposure to exenatide (byetta® or bydureon™) or any glp-1 analog
Beschrijving

Exposure to Exenatide | Exposure to Byetta | Exposure to Bydureon | Exposure to GLP-1 Analogue

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0167117
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1636686
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C3257792
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C3273809
any dpp-4 inhibitor within 3 months prior screening
Beschrijving

Dipeptidyl Peptidase-4 Inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C3537225
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Similar models

Eligibility Diabetes Type 2 NCT01652729

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c of 7.1% to 11.0%, inclusive, at screening
boolean
C0474680 (UMLS CUI [1])
Stable body weight
Item
has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
boolean
C0517386 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose concentration <280 mg/dl (15.5 mmol/l) at screening
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
body mass index of <45 kg/m2 at screening
boolean
C1305855 (UMLS CUI [1])
Metformin Dose Stable U/day
Item
has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to visit 1 (screening)
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Pancreatitis | Triglycerides measurement
Item
history of pancreatitis or triglycerides >=500 mg/dl
boolean
C0030305 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Kidney Transplantation | Dialysis procedure | Estimated creatine clearance
Item
history of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 ml/min
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C1273051 (UMLS CUI [3])
Cardiovascular Disease
Item
active cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Congestive heart failure Severe
Item
presence or history of severe congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
CNS disorder | Epilepsy
Item
central nervous system disease, including epilepsy
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Liver disease
Item
liver disease
boolean
C0023895 (UMLS CUI [1])
Gastrointestinal Diseases Severe (
Item
history of severe gastrointestinal diseases
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Malignant disease
Item
clinically significant malignant disease
boolean
C0442867 (UMLS CUI [1])
Hypoglycemia Severe Repeated
Item
repeated severe hypoglycemia within the last 6 months
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Exposure to Exenatide | Exposure to Byetta | Exposure to Bydureon | Exposure to GLP-1 Analogue
Item
any exposure to exenatide (byetta® or bydureon™) or any glp-1 analog
boolean
C0332157 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1636686 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C3257792 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C3273809 (UMLS CUI [4,2])
Dipeptidyl Peptidase-4 Inhibitor
Item
any dpp-4 inhibitor within 3 months prior screening
boolean
C3537225 (UMLS CUI [1])
Terug naar het begin van de pagina 

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